This is the story of a man and a building, and their tracing of decades — and hints of the future — at Pfizer, and indeed the entire biopharma industry.
When creating and managing electronic documents, document metadata deserves as much attention as document content. Firms that do so can improve compliance and even gain potential competitive advantage by realizing electronic documents (with appropriate metadata) as real business assets.
A Tale of Two Cities by Charles Dickens opens with the famous line, “It was the best of times, it was the worst of times,” referring (in part) to the to conditions in the cities of London and Paris before and during the French Revolution. This parallels two annexes recently updated by the European Medicines Agency (EMA) — one avoids the turmoil (Annex 13), while the other undergoes major upheaval (Annex 1).
When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
Sprinkles have applications for special patient populations, such as infants and young children as well as older adults.
ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).
This application note describes how ReadyToProcess WAVE 25 can help reduce hands-on time as much as 25% in fed-batch culturing, while delivering excellent culture performance. For an optimized perfusion application, the use of intelligent control software enabled accurate regulation of process parameters. Over 100 × 106 viable cells/mL was easily achieved in seven days.
This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
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Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.